CLEANROOM ISO 14644 & HEALTHCARE VERIFICATION HTM 03-01

INTRODUCTION

A range of industries such as healthcare, pharmaceutical, aerospace, food & drink, microelectronics, biotechnology etc. manufacture products or have processes requiring the control of airborne contamination. Cleanrooms operate by controlling the concentration of airborne particles as well as parameters (temperature, relative humidity etc.) to minimise introduction, generation & retention of particles inside the room. In healthcare premises, this is to provide patients & staff with safe & comfortable environments with Specialised Ventilation in place at primary patient treatment areas such as operating departments and isolation wards. Cleanrooms, associated controlled environments & healthcare premises require continuous routine re-verification, testing, monitoring and to provide evidence of continual compliance with the legislation, specific guidance & original design data.

 

THE GUIDANCE & LEGISLATION

DevineAir Limited provides Verification of healthcare premises to all the criteria as detailed in HTM 03-01 part B whilst cleanroom validation services cover compliance to ISO 14644 ‘Cleanrooms & Associated Control Environments’; ISO 14698 ‘Cleanrooms and Associated Control Environments – Biocontamination control’ and EU GMP. The Health & Safety at Work act 1974 is the core legislation that applies to ventilation installations although the CoSHH regulations place upon management, an obligation to ensure that suitable measures are in place to protect their staff & others affected by the work activity.

 

VERIFICATION SERVICE

• Visual assessment of all ventilation & distribution system components
• Particle counts
• Airflow volume and airflow velocity tests
• Room air change rate calculation
• Differential pressure measurement
• In situ HEPA filter testing
• Entrainment test
• Recovery test
• Airflow visualization test
• Containment test
• Temperature and relative humidity
• Noise level measurements
• Lighting level measurements
• Microbiological Air Sampling
• Control system function check

Note: other optional and system specific tests are available.

The final report details all findings & evaluates the cleanroom taking into account design data & the clients specified targets.